Kornimate/medical-research-clean huggingface dataset:
advance® 18ptx® balloon catheter study

Conditions: Peripheral Arterial Disease

Summary: the advance® 18 ptx® balloon catheter study is a clinical trial to study the safety and effectiveness of the advance 18® ptx® balloon catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.


Eligibility criteria:
key inclusion criteria: * age \>18 years. * able to provide informed consent. * has at least one de novo or restenotic lesion(s) with \> 70% stenosis documented angiographically of the sfa or popliteal artery. if more than one lesion requires intervention, only one should be treated as a study lesion. key exclusion criteria: * has significant stenosis (\> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure. * lack of at least one patent runoff vessel with \< 50% stenosis throughout its course. * lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.
an observation study to assess the efficacy and safety of proportional doses of painkyl® in patients with breakthrough cancer pain

Conditions: Cancer Pain

Summary: an open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of painkyl® in patients with breakthrough cancer pain.


Eligibility criteria:
inclusion criteria: 1. cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control; 2. a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer; 3. at least partial relief of breakthrough pain by use of opioid therapy; 4. able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly; 5. willing and able to complete patient diary with each pain episode. 6. 20 to 80 years of age; exclusion criteria: 1. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics; 2. history of hypersensitivity or intolerance to fentanyl; 3. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression; 4. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary; 5. severe (grade 4) mucositis (subjects with less than severe mucositis are permitted and must be instructed to not apply the painkyl® film at a site of inflammation); 6. abnormal oral mucosa which will impede drug absorption; 7. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse; 8. use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study; 9. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
social behavior in depression

Conditions: Depression

Summary: in the project, investigators basically plan to test the difference in social behavior and social cognition between depressive patients and healthy individuals. to test this, investigators plan to use traditional or novel behavioral experiment paradigms to target various behaviors.


Eligibility criteria:
inclusion criteria: * age range between 18 and 60 * education experience above high school * score for hamilton's depression scale \>=17 * diagnosis of depression through scid exclusion criteria: * undergoing electric shock treatment in 3 months * excluding those who with bipolar disorder * excluding those who with postpartum depression * excluding those who with hysteria
a trial evaluating the clinical applicability, correlation, and modeling of cardiac ct using 64 detector row vct

Conditions: Coronary Artery Disease

Summary: to compare computed tomography (ct) images (pictures) of the coronary arteries using the general electric (ge) lightspeed vct scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective diagnostic catheterization or * elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary cta procedure with no intervention performed or change of the patient clinical status. * age ≥18 years but ≤75 years. exclusion criteria: * prior coronary stent implantation * prior coronary artery bypass grafting or other heart surgery * prior pacemaker or internal defibrillator lead implantation * prior artificial heart valve * biochemical renal insufficiency (crserum \> 1.6) or on dialysis * resting hr \> 100 at the time of enrollment * contraindication to β-blockade or calcium channel blocker * nyha-iv * high-grade atrioventricular (av) block * systolic blood pressure \<90 mm hg * severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease * atrial fibrillation * inability to provide informed consent * evidence of ongoing or active clinical instability * acute chest pain (sudden onset) * acute myocardial infarction * cardiac shock * acute pulmonary edema
severe leptospirosis in non-tropical areas

Conditions: Leptospirosis; Intensive Care Unit; Epidemiology; Alveolar Hemorrhage

Summary: leptospirosis is a worldwide zoonosis. the mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis. only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in europe. the investigators conduct a retrospective multi centric study in metropolitan france in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

leptospirosis is a worldwide zoonosis. the infection is acquired through contact with animal urine on contaminated soil. it is an important remerging infectious disease because of its increasing incidence. leptospirosis is most common in tropical and rural settings but its incidence has been constantly increasing for the past ten years in metropolitan france. most of the cases are asymptomatic or sparsely symptomatic, but some patients develop severe leptospirosis (6% to 59%), requiring hospitalisation in intensive care units. the mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis. only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in europe. therefore, the investigators have decided to carry out this studies. the investigators conduct a retrospective multi centric study in metropolitan france in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Eligibility criteria:
inclusion criteria: * patient admitted in icu * leptospirosis confirmed with one laboratory test (mat, elisa, pcr, direct examination) exclusion criteria: * no specific exclusion criteria
effect of multi vitamin and mineral supplementation of liver enzymes and sonography in patient with nafld

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: the study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce nafld

this study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce nafld. participants were randomly selected to participate in the study. then divided into the groups (intervention and placebo). intervention received supplementation for 12 weeks and placebo received same capsule was made for placebo groups.

Eligibility criteria:
inclusion criteria: * participants with nafld diagnosed exclusion criteria: * subjects who in the last 6 months received vitamin or mineral supplementation, those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.
a 12-month study to evaluate the safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures

Conditions: Epilepsy, Partial Seizures; Epilepsy, Primary Generalized Tonic-Clonic Seizures

Summary: study a0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.


Eligibility criteria:
inclusion criteria: * subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits. * male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the screening visit. * diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the international league against epilepsy (ilae 2010) diagnosis criteria. * partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening. * currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening). exclusion criteria: * lennox-gastaut syndrome, infantile spasms, absence seizures, bect (benign epilepsy with centrotemporal spikes), and dravet syndrome, * a current diagnosis of febrile seizures or any febrile seizure within 1 year of screening. * status epilepticus within 1 year prior to visit 1. * seizures related to drugs, alcohol, or acute medical illness. * progressive structural cns lesion or a progressive encephalopathy.

Keywords: safety partial onset seizures primary generalized tonic-clonic seizures pregabalin pediatric adult open-label long term
brain research and integrative neuroscience network for covid-19

Conditions: Cognitive Training; Transcranial Direct Current Stimulation

Summary: the aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long covid. participants will be randomly assigned into two interventions. 1. categorization program (cp) training with active tdcs or 2. categorization program training with sham tdcs.

the two intervention protocols (digitalized cp and nibs) required for this study have been developed and the required equipment (one existing and three new tdcs devices) has been acquired. recruitment for the feasibility study is planned to begin in month 18, i.e., june 2024. changes in the design of the feasibility study have been made by the sc and in coordination with the advisory board. the changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment. specifically, the feasibility study will retain the two-group design (experimental and control). forty participants with pcs will be recruited (instead of seventy, as originally planned). all participants will undergo the diagnostic protocols (the neuroimaging and neuropsychological assessments). then, participants will be randomly assigned into two groups: the experimental, who will receive the active tdcs and cp intervention, and the control group, who will receive the sham tdcs and cp intervention. following the intervention, all participants (experimental and control) will complete a series of dependent measures, including neuropsychological performance and quality of life measures. for neurophysiological measures, electroencephalography (eeg) has been replaced with functional near-infrared spectroscopy (fnirs), which will be conducted both pre- and post-intervention. the current design will require a longer intervention period (as compared to the original design) and the complete delivery of the digitalized cp to maximize treatment effectiveness.

Eligibility criteria:
inclusion criteria: * reported cognitive difficulties due to covid-19 infection * who long covid criteria will be used exclusion criteria: * significant history of neuropsychiatric conditions prior to contracting covid-19; history of neurological conditions such as tbi, cva, ms prior to contracting covid-19.
cardiovascular outcomes in participants with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (acm) or hospitalization for heart failure (hf) for participants with type 2 diabetes mellitus (t2dm) and established cardiovascular (cv) disease among new users of sodium-glucose co-transporter 2 inhibitor (sglt2i) as compared with new users of non-sglt2i anti-hyperglycemic agent (aha).


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (t2dm), defined as: greater than or equal to (\>=) 1 anti-hyperglycemic agent (aha) medication in the study period, and; \>=1 diagnosis of t2dm in any available diagnosis field on or prior to index * established cardiovascular disease, defined as \>=1 diagnosis in any diagnosis field for any of the following conditions: cerebrovascular disease; coronary artery disease (including heart failure \[hf\]); peripheral artery disease * \>=1-year pre-index continuous eligibility; enrollment gaps of less than or equal to (\<=) 30 days will be considered continuous enrollment exclusion criteria: * type 1 diabetes mellitus (t1dm) diagnosis on or prior to the index date * secondary diabetes mellitus (dm) on or prior to the index date * missing sex data
snoring intervention via elevoplasty in a non-surgical clinical environment

Conditions: Snoring

Summary: single group compared to baseline, non-randomized, multi-center, prospective safety \& efficacy study

evaluate the safety and efficacy of the zelegent, inc. elevo™ kit snoring intervention device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis. the zelegent, inc. elevo™ kit snoring intervention device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.

Eligibility criteria:
inclusion criteria: * age \> 22 years (no maximum age) * has consistent bed/sleep partner willing to provide co-participant informed consent * apnea hypopnea index (ahi) of \< 15 verified by polysomnogram (psg) or by snap® diagnostics home sleep study (hss) * has basic computer literacy (e.g., email) and home internet access or smartphone * chronic, simple snoring (verified by bed/sleep partner) * no prior surgical treatment for snoring * bed/sleep partner willing and capable of providing informed consent exclusion criteria: * age \< 22 years * has no consistent bed/sleep partner * apnea hypopnea index (ahi) \> 15 indicative of obstructive sleep apnea * intermittent or occasional snoring * body mass index (bmi) \> 32 kg/m2 * modified mallampati 3 or 4 * tonsil grade 3 or 4+ * significant nasal obstruction * previous palatal surgery * current cigarette smoker * known history of coronary artery disease or stroke * chronic obstructive pulmonary disease (copd) * diabetes (type i or type ii) non-controlled by medical management * major depression or non-controlled psychiatric illness * drug or alcohol abuse * untreated or poorly controlled hypertension * anticoagulation therapy * history of bleeding or clotting disorder * pregnant female
a cohort study of use of doravirine (dor) based regimens in clinical practice in europe doravirine europe real world/

Conditions: HIV I Infection

Summary: following the initiation of doravirine (dor) regimen among people living with hiv (plwh), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period. retrospective data from 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 european sites. the study will be conducted through collaboration with the neat id network, a well-established network of clinical sites across europe.


Eligibility criteria:
inclusion criteria: * are hiv positive male or female * are aged ≥18 years * were prescribed and received at least one dose of dor (without initial dose adjustment). * have started/been switched to dor for at least 12 months at time of data collection * had a resistance genotype available before starting dor * had no evidence of dor-associated resistance mutation * were on dor containing art regimen that also contained 2 fully active nucleos(t)ides and patient had no documented nrti resistance mutations to the two nrtis in the combination. * patients who, at the time of initiation, were: 1. category 1: hiv treatment naïve or 2. category 2: virologically suppressed (hiv-1 rna \<50 copies/ml) for at least 6 months with no evidence of prior virological failure with agents of the nnrti class patients in category 1 and 2 above who have nnrti mutations that do not impact on dor (k103n, y181c, and g190a) using the stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study. exclusion criteria: * patients who have dor as part of their fourth line or higher therapy * patients with prior virological failure with agents of the nnrti class * patients with no documented resistance testing. * patients with no genotype available at dor initiation * patients enrolled in dor trials

Keywords: hiv
vitamin d in bronchiolitis obliterans syndrome

Conditions: Allograft Rejection; Lung Transplantation; Bronchiolitis Obliterans

Summary: vitamin d deficiency occurs in around 50% of our transplant population. preventive treatment with vitamin d (d-cure) can reduce the prevalence of bronchiolitis obliterans syndrome after lung transplantation

* prospective, interventional, randomized, double-blind, placebo-controlled trial. * clinical setting (tertiary university hospital). * investigator-driven, no pharmaceutical sponsor. * lung transplant recipients. * add-on of study-drug (placebo or vitamin d) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol). * 1:1 inclusion ratio (placebo:vitamin d). * randomisation at discharge after informed consent.

Eligibility criteria:
inclusion criteria: * stable ltx recipients at discharge after transplantation. * signed informed consent * adult (age at least 18 years old at moment of transplantation) * able to take oral medication exclusion criteria: * prolonged and/or complicated intensive care unit-course after transplantation. * early (\<30 days post-transplant) post-operative death * major suture problems (airway stenosis or stent) * retransplantation (lung) * previous transplantation (solid organ) * multi-organ transplantation (lung+ other solid organ)

Keywords: organ rejection lung transplantation bronchiolitis obliterans vitamin d prevention
do throat pack used in dental treatments under general anesthesia of patients have an effect on ponv and sore throat?

Conditions: Postoperative Nausea and Vomiting; Sore-throat; Dental Caries

Summary: the aim of this study is to investigate the effect of throat packs on ponv in dental treatments under general anesthesia in special health care needs.

throat packs are widely used to prevent aspiration of blood and other debris, especially in orofacial surgeries and dental treatments performed under general anesthesia. aspiration of blood and other secretions into the stomach is one of the important causes of ponv. there is not much evidence that throat packs prevent nausea and vomiting after surgery. the most critical side effects of throat pack application are sore throat, difficulty swallowing, and being forgotten before extubation. the incidence of cavities and other dental problems is higher in special health care needs due to reasons such as inadequate oral hygiene, malocclusion, high-carbohydrate diet, and lack of awareness about dental health. in this group of patients, dental treatments are primarily performed under general anesthesia. since side effects are more difficult to identify by the patient, the procedures, technical applications and anaesthesia methods should be those with the least potential for side effects. evidence is needed regarding the effect of throat packing on ponv. in this study, researchers planned to investigate the effects of using throat tampons during dental treatments under general anesthesia on ponv and sore throat in participants requiring special health care.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study with parental consent * being between the ages of 5-16 * being grade 1 or 2 according to the asa (american society of anesthesiologists) classification * at least one primary or permanent and one restorative. having undergone treatment (amalgam or composite restoration) exclusion criteria: * having a tracheostomy * being evaluated as having difficult intubation * having an additional disease related to the oesophagus, stomach or intestines, having a percutaneous endoscopic gastrostomy, * having a history of ponv, * having morbid obesity, * having high airway pressure, * having a history of allergy to the drugs to be used, * needing an anaesthetic agent other than the anaesthesia method to be applied * having advanced mental retardation that prevents data collection

Keywords: ponv sore throath throath pack special health care needs